B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL)

M. Balzarotti, Ercole Brusamolino, E. Angelucci, A.M. Carella, U. Vitolo, E. Russo, A. Congiu, M. Gotti, Stefania Massidda, B. Botto, Giorgia Annechini, M. Spina, A. Re, Vittorio Ruggero Zilioli, F. Merli, F. Salvi, Caterina Stelitano, M. Bonfichi, M. Rodari, Roberta MurruMassimo Magagnoli, A. Anastasia, R. Mazza, L. Giordano, A. Santoro

Research output: Contribution to journalArticle

Abstract

This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m2) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed. © 2016 Informa UK Limited, trading as Taylor & Francis Group.
Original languageEnglish
Pages (from-to)2375-2381
Number of pages7
JournalLeukemia and Lymphoma
Volume57
Issue number10
DOIs
Publication statusPublished - 2016

Keywords

  • Chemotherapeutic approaches
  • clinical results
  • lymphoma and Hodgkin lymphoma

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